Cancer Clinical Trial
Official title:
Evaluation of the Impact of a Coordinated Regional Organization to Secure Patient's Care Treated by Oral Antineoplastic Agents
The purpose is to estimate evolution of patients treated by oral neoplastic agents, in term of early or unforeseen recourse to the hospital for adverse events.
Introduction :
Oral antineoplastic agents know a full development in particular targeted therapies. Their
adverse events (AE) lately detected can lead to non compliance or treatment discontinuation
which can be at the origin of disease progression. They can also lead to hospitalization or
recourse to emergency department associating to cost for the society.
Hypothesis :
A coordinated intervention of cancer network in relation with primary healthcare
professionals, would improve safety of care's patient treated with oral antineoplastic agent
by preventing serious AEs through rapid detection.
Primary objective :
The primary objective is to estimate the effect of coordinated intervention of cancer
network, in terms of number of early or unforeseen recourses to hospital for AE, within the
first 6 months after oral neoplastic agent introduction.
Secondary objectives :
The secondary objective is to estimate the effect of coordinated intervention of cancer
network, within the first 6 months after oral neoplastic agent introduction, in terms of
number of hospitalization for AE, number of consultation for AE, number of early or
unforeseen recourses to hospital for grade 1 / 2 AE, number of AE per detection grade, AE
maximal grade, AE all grade, disease progression, the global survival (death for any causes
and for AE), drug dose-intensity taken by the patient during his treatment, number of
recourses to the health care system, quality of life, patient's satisfaction, medical
economic evaluation
Primary outcome :
The main outcome is the number of early or unforeseen recourses to hospital for AE.
Secondary outcomes :
The secondary outcomes are all deaths and deaths from AE, number of hospitalization for AE,
number of consultation for AE, number of early or unforeseen recourses to hospital for grade
1 / 2 AE, disease progression, drug dose-intensity taken by the patient during his
treatment, number of recourses to the health care system, number of AE per detection grade,
AE maximal grade, AE all grade, quality of life, patient's satisfaction, medical economic
evaluationMethodology, design :
A comparative, controlled, not randomized, multicenter, prospective, "quasi-experimental"
study, allows estimating evolution of patients according to the existence of a cancer
network in their residence place.
Number of needed subjects: 440 patients.
Total duration of the study: 27 months. Inclusion Period: 21 months. length of participation
period for one patient: 6 months. Number of participating centers: 21. Average number of
inclusions a month by center: 4.
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